NCT04639869

Bioequivalence Study of Feniramidol HCl 400 mg Film Tablet (Pharmactive, Turkey) Under Fed Conditions

Open-label, Randomized, Single Dose, 4period, Replicated, Cross-over Trial to Assess the Bioequivalence of Feniramidol HCl 400 mg Film Tablet in Comparison With Cabral 400 mg Film Tablet in Healthy Male Subjects Under Fed Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Humanis Saglık Anonim Sirketi · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

OPEN-LABEL, RANDOMISED, SINGLE ORAL DOSE, FOUR-PERIOD, REPLICATED, CROSS-OVER TRIAL TO ASSESS THE BIOEQUIVALENCE OF FENIRAMIDOL HCl 400 MG FILM TABLET (TEST DRUG) IN COMPARISON WITH CABRAL 400 MG FILM TABLET (REFERENCE DRUG) IN HEALTHY MALE SUBJECTS UNDER FED CONDITIONS

Detailed description

Phenyramidol shows its muscle relaxant activity by interneuronal blockage without disrupting neuromuscular function. Thus, it relieves muscle spasm, and breaks pain-spasm chain by blocking polisynaptic reflexes in the brain and medulla spinalis. It does not affect monosynaptic reflexes. Phenyramidol has a very high analgesic effect than aspirin and close to codeine. It used in the treatment of acute and chronic human musculoskeletal system pains as muscle relaxant and analgesic. Pharmacokinetics Phenyramidol reaches maximum plasma concentration in an hour (0.25-1) after absorption from gastrointestinal tract. It is widely distributed in skeletal muscles and involved in circulatory system very slowly. Studies have shown that cytochrome P450 enzymes are effective in phenyramidol metabolism. It is conjugated with glucuronic acid in the liver and it is excreted as glucuronide conjugates from the urinary tract. The drug is eliminated from the bile and the bacterial glucuronidase enzymes make the glucuronide conjugate of phenyramidol free. The drug enters enterohepatic circulation and is excreted by faeces. Its elimination half-life is 1-2 hours. Indications Phenyramidol is indicated in the symptomatic treatment of acute painful muscle spasms associated with musculoskeletal system.

Conditions

• Bioequivalence

Interventions

Type	Name	Description
DRUG	Phenyramydol HCl 400 mg Film Tablet	Phenyramydol HCL 400 mg Film Tablet contains 400 mg phenyramydol manufactured by Pharmactive Ilac.San ve Tic A.S
DRUG	Cabral 400 mg Film Tablet	Cabral 400 mg Film Tablet 400 mg phenyramydol manufactured by Recordati Ilac SAn ve Tic A.S.

Timeline

• Start date: 2019-06-26
• Primary completion: 2019-07-26
• Completion: 2019-08-27
• First posted: 2020-11-23
• Last updated: 2023-09-28

Locations

1 site across 1 country: Turkey (Türkiye)